Safety Report: Teligent Pharma, Inc. Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) - recalled due to Super Potent, USA

United States

Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.

Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.

- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle. NDC: 52565-009-50. Lot number/Expiration: 13262 / 03/2022 | 14217 / 08/2022 | 13058 / 02/2022 | 13768 / 05/2022. NDC: 63739-997-64. Lot number/Expiration: 16306 01/2024

The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50 and 63739-997-64. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). Product was distributed at the wholesale and retail distribution levels in the US and Canada.

Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products.

Consumers and patients that have Lidocaine HCl Topical Solution 4% which is being recalled are asked to discontinue use and dispose of the product immediately.

Company name: Teligent Pharma, Inc.
Brand name: Teligent Pharma, Inc.
Product recalled: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)
Reason of the recall: Super Potent
FDA Recall date: October 12, 2021

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-worldwide-voluntary-recall-lidocaine-hcl-topical-solution-4-due-super

Source: FDA